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Financial Conflicts of Interest for Awardees—NIAID Staff Response

Purpose

To delineate staff roles in making sure financial interests at awardee institutions do not affect the design, conduct, or reporting of research funded under NIAID grants or cooperative agreements (SBIR phase I awards are exempt).

Procedure

By law, institutions must manage, reduce, or eliminate financial conflicts of interest (FCOI) for any person—including subawardees and collaborators—responsible for designing, conducting, or reporting NIAID-funded research.

They also have to report financial conflicts of interest through the eRA Commons before spending funds on a new grant, or within 60 days of learning about a conflict on a funded grant.

Staff review incoming reports and prioritize incidents that have the highest risk of tainting NIAID-funded research.

NIAID's financial conflict of interest liaison leads any response. When appropriate, the liaison brokers a response with the NIH Office of Extramural Research.

All Staff

Discuss an incident only with PIs, institutional business officials, and staff identified in this SOP. Do not provide advice or guidance to anybody except the financial conflict of interest liaison, chief grants management officer, and grants management specialist.

In all cases where you become aware of a possible financial conflict of interest, email the information to the financial conflict of interest liaison and copy the chief grants management officer.

In the following situations, also take the additional steps below:

Notifications directly from PIs.

Tell them to contact their institutions. Get the PI's grant number and the name of the institution.

For multiproject grants, discuss the conflict with program director only. Refer other PIs to the program director, and instruct them to contact their institutions.

For multiple PI grants, discuss the conflict with the contact PI only. Refer other PIs to the contact PI.

When you send the email described above, copy the grants management specialist, program officer, division coordinator, and division FCOI contact for the award.

Notifications from third parties—e.g., peer reviewers or other investigators.

Tell the liaison only. These types of inquiries should go through official NIH channels.

You don't have to alert anybody else.

Program Officers

Hewing to internal divisional procedures, review notifications from grants management specialists and assess whether the conflict involves any of the following programmatic high-risk situations:

Clinical research involving any of the following:

High risk populations.

Multisite components.

Clinical trials.

FDA-regulated drugs or devices.

One or more sites outside a clinical trials network.

An investigator associated with an industry connected to the research.

An individual who plays a critical role in the research.

If the conflict doesn't fall into a high risk category, send the specialist a memo that says "Research does not fall into an NIAID administrative or programmatic high-risk category with regard to FCOI," and copy your division FCOI contact and division coordinator.

If the conflict falls into a high-risk category, do the following:

Notify the specialist.

Cosign a request for synopsis. The specialist has a template for this request.

Verify that the notification letter includes the information listed in the Financial Conflict of Interest for Awardees SOP under Applicants, Offerors, and Awardees. If the letter is missing any information, follow up with the grantee.

Work with the program officer to assess whether the conflict falls into a programmatic high-risk category.

Be available for follow-up meetings if called upon.

If you hear about a financial conflict of interest directly from a PI, follow the instructions for all staff but also contact the institution in question to remind it of the NIH policy on reporting conflicts.